Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.
- Prince Of Spray Drying Returns As Earl Of Dispersion
- CDMO Partnerships In Early Development Aren’t Always The Best Choice
- Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences
- Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
- 5 Steps To Eliminate Weak Links In Your Data Governance
- Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
- Modularity And Mobility Hold The Keys To Surge Manufacturing
Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences
Rising interest rates, imploding cryptocurrencies, and erratic equities markets have upended assumptions about risk and returns during 2022. The “risk-free” rate has surged to more than 4% as of late November. Your pharma, biotech, or medical device company looking to raise cash needs to take the key considerations shared in this article into account.
Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.
5 Steps To Eliminate Weak Links In Your Data Governance
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
Modularity And Mobility Hold The Keys To Surge Manufacturing
When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.
Create The Correct Checklist To Land The Best CDMO
When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
The Fruits Of Synthetic Biology
Can cell and gene therapies be programmed with sophisticated behaviors, to sense, make decisions, and treat important diseases effectively? Synthetic gene circuits may hold the key.
A Methodology To Support Particle Investigations In Biopharma Products
Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
PHARMA OUTSOURCING WHITE PAPERS
The Science Of Cell Therapy Thawing
A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.
Strategies For Accelerating The Development Of Modified Release Oral Forms
Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.
How Dwell Volume And Extra-Column Volume Impact Method Transfer
Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.
Path Towards Efficient Pediatric Formulation Development Based On Partnering With Clinical Pharmacologists And Clinicians
Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
21 CFR Part 11 — Are You Ready For An FDA Inspection?
Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.
A Guide To Pharmaceutical Quality Management
Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing.
The “Outsourcing Master Class” is a capstone-case-review, team-based course sanctioned by the International Association of Outsourcing Professionals (IAOP). Designed by Darren Dasburg, Chief Business Officer, CRISPR Biotech, these time-tested outsourcing fundamentals offer you a blueprint to keep teams working together on both sides.More Content Collections